Expert Review of Cardiovascular Therapy
ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20
Primary prevention implantable cardioverterdefibrillator implantation in elderly patients: is it justified to withhold treatment? Aafke C van der Heijden, Lieselot van Erven, Martin J Schalij & C Jan Willem Borleffs To cite this article: Aafke C van der Heijden, Lieselot van Erven, Martin J Schalij & C Jan Willem Borleffs (2014) Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment?, Expert Review of Cardiovascular Therapy, 12:7, 787-789 To link to this article: http://dx.doi.org/10.1586/14779072.2014.908704
Published online: 16 Apr 2014.
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Article views: 42
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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierk20 Download by: [Chinese University of Hong Kong]
Date: 07 November 2015, At: 18:38
Editorial
Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment? Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
Expert Rev. Cardiovasc. Ther. 12(7), 787–789 (2014)
Aafke C van der Heijden Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
Lieselot van Erven Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
Martin J Schalij Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
C Jan Willem Borleffs Author for correspondence: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands Tel.: +31 715 262 020 Fax: +31 715 266 809 [email protected]
Implementation of primary prevention implantable cardioverter-defibrillator (ICD) treatment in the current clinical guidelines led to a significant increase in patients that may benefit from implantation of an ICD. Currently non-guideline-guided patient selection takes place by physicians whereby patients at higher age are more frequently excluded for ICD implantation. This editorial focuses on ICD treatment in the elderly and aims to clarify whether it is justified to withhold ICD treatment in these patients.
Sudden cardiac death (SCD) remains a leading cause of death worldwide. It is most frequently caused by ventricular tachycardia, degenerating into ventricular fibrillation [1]. In the western population, the survival rate of such a sudden cardiac arrest is barely 10% [2]. Patients with structural heart disease of either ischemic or nonischemic cause resulting in impaired left ventricular ejection fraction (LVEF) are at high risk for SCD [3]. Large randomized controlled trials have demonstrated that the implantation of an implantable cardioverterdefibrillator (ICD) reduces all-cause mortality, first in patients resuscitated from an episode of ventricular tachycardia or fibrillation (secondary prevention), and thereafter also in patients with depressed LVEF (79 years) and patients with comorbidities are more frequently excluded from ICD treatment [10]. This may have derived from the fact that patients enrolled in the large trials were relatively young and had little comorbidities. Furthermore, additional research focused on ICD benefit in elderly patients remains scarce and results are controversial [11,12]. But is it really justified to withhold ICD treatment in elderly patients? Age & effectiveness of ICD treatment
In current routine clinical practice, more than 40% of the ICD recipients are at least 70 years old, and due to the aging of the population, the number of elderly patients qualifying for ICD is increasing rapidly [13]. Although ICD treatment is clearly beneficial for the reduction of mortality in patients with depressed systolic heart function, it remains questionable if this is also the
KEYWORDS: comorbidities • elderly • implantable cardioverter-defibrillator • primary prevention • sudden cardiac death
informahealthcare.com
10.1586/14779072.2014.908704
2014 Informa UK Ltd
ISSN 1477-9072
787
Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
Editorial
van der Heijden, van Erven, Schalij & Borleffs
case in patients with shorter life expectancy, such as the elderly. Since the risk of sudden cardiac events increases with age, ICD treatment may be even more beneficial in older patients. On the other hand, elderly patients also have a higher burden of comorbidities, and therefore, may be at disproportionally higher risk of non-SCD, which may diminish the beneficial effect of ICD treatment. Even though elderly patients were not excluded from the pivotal trials, they were largely under-represented. The mean age of patients included in these trials did not exceed 65 years [5,8]. By including 204 (17%) patients aged ‡75 years, the elderly were best represented in the second Multicenter Automatic Defibrillator Implantation Trial (MADIT-II), which enrolled patients with prior myocardial infarction and LVEF 70 years, NYHA functional class >II, QRS duration >120 ms, history of atrial fibrillation and blood urea nitrogen >26 mg/dl. The risk of mortality in the 200 (16.8%) patients with three or more risk factors was five-times higher, and more importantly ICD treatment did not improve the survival since the mortality in both study arms (ICD vs nonICD) was similar. This emphasizes the importance of considering age and the burden of comorbidities before ICD implantation. Future of device treatment in frail elderly
Although data on the effect of ICD treatment in the elderly, especially with comorbidities, are scarce, current literature suggests that this population has less or even no benefit from ICD treatment as compared to their younger peers. Age itself should not be the sole criterion for withholding treatment but to optimize allocation of ICD treatment, one should realize that in a population with high age and concomitant comorbidities, the small potential benefits of ICD treatment might not outweigh the costs and burden of device-related complications. Financial & competing interests disclosure
The department of cardiology received unrestricted research grants from Biotronik, Boston Scientific, GE Healthcare, Medtronic and St. Jude Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Expert Rev. Cardiovasc. Ther. 12(7), (2014)
Primary prevention ICD treatment in elderly
References 1.
Zipes DP, Wellens HJ. Sudden cardiac death. Circulation 1998;98(21):2334-51
2.
Mehra R. Global public health problem of sudden cardiac death. J Electrocardiol 2007; 40(6 Suppl):S118-22
3.
Rouleau JL, Talajic M, Sussex B, et al. Myocardial infarction patients in the 1990s– their risk factors, stratification and survival in Canada: the Canadian Assessment of Myocardial Infarction (CAMI) Study. J Am Coll Cardiol 1996;27(5):1119-27
Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
4.
5.
6.
7.
8.
A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med 1997;337(22):1576-83 Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352(3):225-37
9.
Hlatky MA, Mark DB. The high cost of implantable defibrillators. Eur Heart J 2007; 28(4):388-91
10.
Borleffs CJ, Wilde AA, Cramer MJ, et al. Clinical implementation of guidelines for cardioverter defibrillator implantation: lost in translation? Neth Heart J 2007;15(4): 129-32
11.
Groeneveld PW, Laufer SB, Garber AM. Technology diffusion, hospital variation and racial disparities among elderly Medicare beneficiaries 1989-2000. Med Care 2005; 43(4):320-9
12.
van Rees JB, Borleffs CJ, Thijssen J, et al. Prophylactic implantable cardioverter-defibrillator treatment in the elderly: therapy, adverse events, and survival gain. Europace 2012;14(1):66-73
13.
Epstein AE, Kay GN, Plumb VJ, et al. Implantable cardioverter-defibrillator prescription in the elderly. Heart Rhythm 2009;6(8):1136-43
14.
Huang DT, Sesselberg HW, McNitt S, et al. Improved survival associated with prophylactic implantable defibrillators in elderly patients with prior myocardial infarction and depressed ventricular function: a MADIT-II substudy. J Cardiovasc Electrophysiol 2007;18(8):833-8
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004; 350(21):2151-8 Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996;335(26): 1933-40 Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346(12):877-83
informahealthcare.com
15.
16.
17.
Santangeli P, Di Biase L, Dello Russo A, et al. Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillators. Ann Intern Med 2010;153(9):592-9 Kong MH, Al-Khatib SM, Sanders GD, et al. Use of implantable cardioverter-defibrillators for primary prevention in older patients: a systematic literature review and meta-analysis. Cardiol J 2011;18(5):503-14 Suleiman M, Goldenberg I, Haim M, et al. Clinical characteristics and outcomes of elderly patients treated with an implantable
Editorial
cardioverter-defibrillator or cardiac resynchronization therapy in a real-world setting: data from the Israeli ICD Registry. Heart Rhythm 2014;11(3):435-41 18.
Yung D, Birnie D, Dorian P, et al. Survival after implantable cardioverter-defibrillator implantation in the elderly. Circulation 2013;127(24):2383-92
19.
Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008;117(21). e350-408
20.
Korantzopoulos P, Liu T, Li L, et al. Implantable cardioverter defibrillator therapy in chronic kidney disease: a meta-analysis. Europace 2009;11(11):1469-75
21.
Lee DS, Tu JV, Austin PC, et al. Effect of cardiac and noncardiac conditions on survival after defibrillator implantation. J Am Coll Cardiol 2007;49(25):2408-15
22.
Bhavnani SP, Coleman CI, Guertin D, et al. Evaluation of the Charlson comorbidity index to predict early mortality in implantable cardioverter defibrillator patients. Ann Noninvasive Electrocardiol 2013;18(4):379-88
23.
Goldenberg I, Vyas AK, Hall WJ, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. J Am Coll Cardiol 2008;51(3):288-96
789
ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20
Primary prevention implantable cardioverterdefibrillator implantation in elderly patients: is it justified to withhold treatment? Aafke C van der Heijden, Lieselot van Erven, Martin J Schalij & C Jan Willem Borleffs To cite this article: Aafke C van der Heijden, Lieselot van Erven, Martin J Schalij & C Jan Willem Borleffs (2014) Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment?, Expert Review of Cardiovascular Therapy, 12:7, 787-789 To link to this article: http://dx.doi.org/10.1586/14779072.2014.908704
Published online: 16 Apr 2014.
Submit your article to this journal
Article views: 42
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierk20 Download by: [Chinese University of Hong Kong]
Date: 07 November 2015, At: 18:38
Editorial
Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment? Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
Expert Rev. Cardiovasc. Ther. 12(7), 787–789 (2014)
Aafke C van der Heijden Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
Lieselot van Erven Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
Martin J Schalij Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands
C Jan Willem Borleffs Author for correspondence: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, The Netherlands Tel.: +31 715 262 020 Fax: +31 715 266 809 [email protected]
Implementation of primary prevention implantable cardioverter-defibrillator (ICD) treatment in the current clinical guidelines led to a significant increase in patients that may benefit from implantation of an ICD. Currently non-guideline-guided patient selection takes place by physicians whereby patients at higher age are more frequently excluded for ICD implantation. This editorial focuses on ICD treatment in the elderly and aims to clarify whether it is justified to withhold ICD treatment in these patients.
Sudden cardiac death (SCD) remains a leading cause of death worldwide. It is most frequently caused by ventricular tachycardia, degenerating into ventricular fibrillation [1]. In the western population, the survival rate of such a sudden cardiac arrest is barely 10% [2]. Patients with structural heart disease of either ischemic or nonischemic cause resulting in impaired left ventricular ejection fraction (LVEF) are at high risk for SCD [3]. Large randomized controlled trials have demonstrated that the implantation of an implantable cardioverterdefibrillator (ICD) reduces all-cause mortality, first in patients resuscitated from an episode of ventricular tachycardia or fibrillation (secondary prevention), and thereafter also in patients with depressed LVEF (79 years) and patients with comorbidities are more frequently excluded from ICD treatment [10]. This may have derived from the fact that patients enrolled in the large trials were relatively young and had little comorbidities. Furthermore, additional research focused on ICD benefit in elderly patients remains scarce and results are controversial [11,12]. But is it really justified to withhold ICD treatment in elderly patients? Age & effectiveness of ICD treatment
In current routine clinical practice, more than 40% of the ICD recipients are at least 70 years old, and due to the aging of the population, the number of elderly patients qualifying for ICD is increasing rapidly [13]. Although ICD treatment is clearly beneficial for the reduction of mortality in patients with depressed systolic heart function, it remains questionable if this is also the
KEYWORDS: comorbidities • elderly • implantable cardioverter-defibrillator • primary prevention • sudden cardiac death
informahealthcare.com
10.1586/14779072.2014.908704
2014 Informa UK Ltd
ISSN 1477-9072
787
Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
Editorial
van der Heijden, van Erven, Schalij & Borleffs
case in patients with shorter life expectancy, such as the elderly. Since the risk of sudden cardiac events increases with age, ICD treatment may be even more beneficial in older patients. On the other hand, elderly patients also have a higher burden of comorbidities, and therefore, may be at disproportionally higher risk of non-SCD, which may diminish the beneficial effect of ICD treatment. Even though elderly patients were not excluded from the pivotal trials, they were largely under-represented. The mean age of patients included in these trials did not exceed 65 years [5,8]. By including 204 (17%) patients aged ‡75 years, the elderly were best represented in the second Multicenter Automatic Defibrillator Implantation Trial (MADIT-II), which enrolled patients with prior myocardial infarction and LVEF 70 years, NYHA functional class >II, QRS duration >120 ms, history of atrial fibrillation and blood urea nitrogen >26 mg/dl. The risk of mortality in the 200 (16.8%) patients with three or more risk factors was five-times higher, and more importantly ICD treatment did not improve the survival since the mortality in both study arms (ICD vs nonICD) was similar. This emphasizes the importance of considering age and the burden of comorbidities before ICD implantation. Future of device treatment in frail elderly
Although data on the effect of ICD treatment in the elderly, especially with comorbidities, are scarce, current literature suggests that this population has less or even no benefit from ICD treatment as compared to their younger peers. Age itself should not be the sole criterion for withholding treatment but to optimize allocation of ICD treatment, one should realize that in a population with high age and concomitant comorbidities, the small potential benefits of ICD treatment might not outweigh the costs and burden of device-related complications. Financial & competing interests disclosure
The department of cardiology received unrestricted research grants from Biotronik, Boston Scientific, GE Healthcare, Medtronic and St. Jude Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Expert Rev. Cardiovasc. Ther. 12(7), (2014)
Primary prevention ICD treatment in elderly
References 1.
Zipes DP, Wellens HJ. Sudden cardiac death. Circulation 1998;98(21):2334-51
2.
Mehra R. Global public health problem of sudden cardiac death. J Electrocardiol 2007; 40(6 Suppl):S118-22
3.
Rouleau JL, Talajic M, Sussex B, et al. Myocardial infarction patients in the 1990s– their risk factors, stratification and survival in Canada: the Canadian Assessment of Myocardial Infarction (CAMI) Study. J Am Coll Cardiol 1996;27(5):1119-27
Downloaded by [Chinese University of Hong Kong] at 18:38 07 November 2015
4.
5.
6.
7.
8.
A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med 1997;337(22):1576-83 Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352(3):225-37
9.
Hlatky MA, Mark DB. The high cost of implantable defibrillators. Eur Heart J 2007; 28(4):388-91
10.
Borleffs CJ, Wilde AA, Cramer MJ, et al. Clinical implementation of guidelines for cardioverter defibrillator implantation: lost in translation? Neth Heart J 2007;15(4): 129-32
11.
Groeneveld PW, Laufer SB, Garber AM. Technology diffusion, hospital variation and racial disparities among elderly Medicare beneficiaries 1989-2000. Med Care 2005; 43(4):320-9
12.
van Rees JB, Borleffs CJ, Thijssen J, et al. Prophylactic implantable cardioverter-defibrillator treatment in the elderly: therapy, adverse events, and survival gain. Europace 2012;14(1):66-73
13.
Epstein AE, Kay GN, Plumb VJ, et al. Implantable cardioverter-defibrillator prescription in the elderly. Heart Rhythm 2009;6(8):1136-43
14.
Huang DT, Sesselberg HW, McNitt S, et al. Improved survival associated with prophylactic implantable defibrillators in elderly patients with prior myocardial infarction and depressed ventricular function: a MADIT-II substudy. J Cardiovasc Electrophysiol 2007;18(8):833-8
Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004; 350(21):2151-8 Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996;335(26): 1933-40 Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346(12):877-83
informahealthcare.com
15.
16.
17.
Santangeli P, Di Biase L, Dello Russo A, et al. Meta-analysis: age and effectiveness of prophylactic implantable cardioverter-defibrillators. Ann Intern Med 2010;153(9):592-9 Kong MH, Al-Khatib SM, Sanders GD, et al. Use of implantable cardioverter-defibrillators for primary prevention in older patients: a systematic literature review and meta-analysis. Cardiol J 2011;18(5):503-14 Suleiman M, Goldenberg I, Haim M, et al. Clinical characteristics and outcomes of elderly patients treated with an implantable
Editorial
cardioverter-defibrillator or cardiac resynchronization therapy in a real-world setting: data from the Israeli ICD Registry. Heart Rhythm 2014;11(3):435-41 18.
Yung D, Birnie D, Dorian P, et al. Survival after implantable cardioverter-defibrillator implantation in the elderly. Circulation 2013;127(24):2383-92
19.
Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008;117(21). e350-408
20.
Korantzopoulos P, Liu T, Li L, et al. Implantable cardioverter defibrillator therapy in chronic kidney disease: a meta-analysis. Europace 2009;11(11):1469-75
21.
Lee DS, Tu JV, Austin PC, et al. Effect of cardiac and noncardiac conditions on survival after defibrillator implantation. J Am Coll Cardiol 2007;49(25):2408-15
22.
Bhavnani SP, Coleman CI, Guertin D, et al. Evaluation of the Charlson comorbidity index to predict early mortality in implantable cardioverter defibrillator patients. Ann Noninvasive Electrocardiol 2013;18(4):379-88
23.
Goldenberg I, Vyas AK, Hall WJ, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. J Am Coll Cardiol 2008;51(3):288-96
789
